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Follow-On Biologics: Implementation Challenges and Opportunities

The March 23, 2010, enactment of the Patient Protection and Affordable Care Act (PPACA) and the companion Health Care and Education Affordability Reconciliation Act of 2010 ushered in landmark reform of the American health care system. Along with sweeping overhauls of the health care system generally, PPACA also provides a new regulatory challenge for the Food and Drug Administration (FDA). A subtitle within PPACA, the Biologics Price Competition and Innovation Act (BPCIA), bestows upon FDA broad authority to implement an abbreviated approval route to market for biological products (also known as biologics) that are “biosimilar” to an existing marketed product. This brief article will provide a basic comparison of biologics and conventional pharmaceutical drugs that will prove central to the FDA’s development of this follow-on biologic pathway as well as specifically examine the content and scope of the BPCIA provisions and identify future challenges for the FDA. It will conclude by highlighting details of presentations during the roundtable held at the Seton Hall University School of Law and introduce the two resulting articles contained within Volume 41 of the Seton Hall Law Review.